IntelGenx Technologies Corp.

Thank you. Good afternoon, everyone.

And thank you for joining us on today's call. With me on the line or Dr.

Horst Zerbe, IntelGenx CEO, Andre Goden, our President and CFO, Tommy Kenny, our General Counsel and Dr. Dana Madson, the Company's Vice President of the Business and Corporate Development.

Before we begin, I would like to remind you that all amounts mentioned today are in US dollars unless otherwise mentioned and today's call may contain forward-looking information that represents our expectations as of today, and accordingly are subject to change. We do not undertake any obligation to update any forward-looking statements, except as may be required by US and Canadian securities laws.

A number of assumptions were made by us in preparing these forward-looking statements, which are subject to risks and results may differ materially. Details on the risks and assumptions can be found in our filings with the US and Canadian securities commissions.

I'd like now to turn the call over to Dr. Zerbe.

Horst? [Author ID1: at Fri Mar 25 12:32:00 2022 ] [[Author ID1: at Fri Mar 25 12:32:00 2022 ]1:20[Author ID1: at Fri Mar 25 12:33:00 2022 ]][Author ID1: at Fri Mar 25 12:32:00 2022 ]

Thank you, Steve. Good afternoon, everyone and -- fourth quarter and full year 2021 conference call.

On today's call, I will provide a corporate update and discuss the progress we have made on our key pipeline projects. Then today we'll review our Q4 and full year 2021 financial results.

Following that, we will open up the line for your questions. First on our atai partnership in March of last year, we announced our strategic partnership with a [Author ID1: at Fri Mar 25 12:36:00 2022 ]atai Life Sciences, which has positioned us as a leading developer and manufacturer[Author ID1: at Fri Mar 25 12:37:00 2022 ] in the psychedelic therapeutic space while also providing the financial capacity to continue progressing our pharmaceutical film product candidates towards commercialization.

In connection with this partnership, atai acquired approximately 25% of IntelGenx for approximately $12.3 million and granted us an initial secured loan in the amount of $2 million. atai subsequentl[Author ID1: at Fri Mar 25 12:37:00 2022 ]y[Author ID1: at Fri Mar 25 12:38:00 2022 ] granted us a second secured loan in the amount of $500,000.

In May we entered into a second feasibility agreement with atai for the development of novel formulations of Salvinorin A, a naturally occurring psychedelic compound based on IntelGenx's primary film technologies. In September, we entered into an amended and restated secured loan agreement with atai, which committed $6 million in future financial support to IntelGenx.

This loan was required for us to meet certain requirements in conjunction with our uplifting [Author ID1: at Fri Mar 25 12:39:00 2022 ]up[Author ID1: at Fri Mar 25 12:39:00 2022 ]-[Author ID1: at Fri Mar 25 12:39:00 2022 ]li[Author ID1: at Fri Mar 25 12:39:00 2022 ]s[Author ID1: at Fri Mar 25 12:39:00 2022 ]ting [Author ID1: at Fri Mar 25 12:39:00 2022 ]to the TSX big board. Our stock began trading[Author ID1: at Fri Mar 25 12:39:00 2022 ]e[Author ID1: at Fri Mar 25 12:39:00 2022 ] on Canada's most senior exchange on October 7.

Our graduation to the TSX marks an important milestone for IntelGenx and should support the development of a stronger profile in the investment community. Last month, we received a third term loan from atai in the amount of $3 million.

We look forward to continuing to work with ATAI, to develop more efficacious treatments for patients with treatment resistant depression and other mental health indications. Moving on to RIZAPORT, in September, we were pleased to announce that Exeltis our RIZAPORT commercialization partner in 27 European Union countries launched RIZAPORT in Spain.

This was the first versa film based product to launch in the global pharmaceutical market and was a major milestone for IntelGenx. With the European migraine drug market expected to approach $1.5 million by 2024, we are looking forward to working with Exeltis to launch re support[Author ID1: at Fri Mar 25 12:41:00 2022 ]RIZAPORT*[Author ID1: at Fri Mar 25 12:41:00 2022 ] in additional European countries in the future.

Two [Author ID1: at Fri Mar 25 12:41:00 2022 ]Few[Author ID1: at Fri Mar 25 12:41:00 2022 ] [Author ID1: at Fri Mar 25 12:41:00 2022 ]words on Tadalafil, in September, we announced that Aquestive Therapeutics our co-development and commercialization partner for Tadalafil oral films entered into a definitive license and supply agreement with an undisclosed leading men's health company. This is an important development in our collaboration with Aquestive that will help make Tadalafil oral films available to men's suffering from erectly[Author ID1: at Fri Mar 25 12:42:00 2022 ] [Author ID1: at Fri Mar 25 12:42:00 2022 ]erectile*[Author ID1: at Fri Mar 25 12:42:00 2022 ] [Author ID1: at Fri Mar 25 12:42:00 2022 ]dysfunction and benign prosthetic hyperplasia or BPH.

On cannabis films, in February of last year, the United States patent and trademark office granted a notice of allowance for our US patent application covering novel disintegrating oral film formulations designed for the transmucosal absorption of drug, especially Tetrahydrocannabinol or THC. This patent is intended to protect our D[Author ID1: at Fri Mar 25 12:44:00 2022 ]isinte[Author ID1: at Fri Mar 25 12:43:00 2022 ]Q*[Author ID1: at Fri Mar 25 12:44:00 2022 ] [Author ID1: at Fri Mar 25 12:43:00 2022 ]products, which enable THC absorption via the oral cavity, thus minimizing the amount of THC that becomes subjected to unwanted oral first pass metabolism.

In August, we transitioned from a development to commercial stage company by completing our initial shipment of CBD Filmstrips in support of Heritage Cannabis launch of the CB4[Author ID1: at Fri Mar 25 12:47:00 2022 ] four[Author ID1: at Fri Mar 25 12:47:00 2022 ] control brand in Canada. We're looking forward to continuing to work with Heritage on oral thin film cannabis products.

On Montelukast, in January, we were finally able to resume patient enrolment and dosing in our Phase II BUENA clinical trial in patients with mild to moderate Alzheimers disease. This proof of concept study is proceeding under the [[Author ID1: at Fri Mar 25 12:48:00 2022 ]amended] (ph)[Author ID1: at Fri Mar 25 12:48:00 2022 ] protocol with a higher daily dose that was previously cleared by Health Canada.

We're looking forward to collecting value of the data on Montelukast versa film safety, feasibility, tolerability and efficacy for the treatment of mild to moderate Alzheimer's disease. In addition, we expect to explore the products candidates efficacy in a couple of other major indications.

We hope to announce those details soon. Now, a few words on animal health.[Author ID1: at Fri Mar 25 12:49:00 2022 ],[Author ID1: at Fri Mar 25 12:49:00 2022 ] In February of last year, IntelGenx filed a new provisional patent application at the US PTO that covers the incorporation of high concentrations of active ingredients in products based on our better film[Author ID1: at Fri Mar 25 12:50:00 2022 ]VetaFilm*[Author ID1: at Fri Mar 25 12:50:00 2022 ] proprietary veterinary oral*[Author ID1: at Fri Mar 25 12:50:00 2022 ] film technology.

This higher loading capability enables a formulation with the ratio of active to [Author ID1: at Fri Mar 25 12:50:00 2022 ]polymer of one to one. So this new patent will allow us to incorporate high amounts of drug into our film while still keeping it small enough to administer easily to companion animals.

Back in early 2020, we entered into a feasibility study agreement with an undisclosed partner with [Author ID1: at Fri Mar 25 12:51:00 2022 ]for[Author ID1: at Fri Mar 25 12:51:00 2022 ] [Author ID1: at Fri Mar 25 12:51:00 2022 ]an undisclosed molecule for undisclosed molecule for [Author ID1: at Fri Mar 25 12:51:00 2022 ]buckle [Author ID1: at Fri Mar 25 12:52:00 2022 ]buccal*[Author ID1: at Fri Mar 25 12:52:00 2022 ] [Author ID1: at Fri Mar 25 12:52:00 2022 ]absorption using IntelGenx proprietary be[Author ID1: at Fri Mar 25 12:52:00 2022 ]ta [Author ID1: at Fri Mar 25 12:52:00 2022 ]Veta[Author ID1: at Fri Mar 25 12:52:00 2022 ]Film*[Author ID1: at Fri Mar 25 12:52:00 2022 ] platform. This feasibility study was successful and in October of 2021, we entered into an additional R&D agreement with this undisclosed company to further optimize the buckle [Author ID1: at Fri Mar 25 12:52:00 2022 ]Buccal*[Author ID1: at Fri Mar 25 12:52:00 2022 ] [Author ID1: at Fri Mar 25 12:52:00 2022 ]film and to manufacture films for clinical study.

And with that, I would now like to turn the call over to Andre for a review of our financial results. Andre?

Thank you Horst. Good afternoon, everyone.

As Horst mentioned, I'd like to take a few minutes to discuss the company's financial performance for the fourth quarter, as well as the full fiscal year ended December 31, 2021. For the fourth[Author ID1: at Fri Mar 25 12:53:00 2022 ] quarter of 2021, the total revenue amounted to $494,000 compared to $790,000 in the same period last year.

The change is mainly attributable to a $425,000 decrease in revenue from licensing agreement received[Author ID1: at Fri Mar 25 12:53:00 2022 ]ing[Author ID1: at Fri Mar 25 12:53:00 2022 ] in [Author ID1: at Fri Mar 25 12:53:00 2022 ]2020 and that was partially offset by increases in R&D revenues of $94,000 and product revenues of $35,000. Operating costs and expenses were $3 million for the Q4 2021 versus $1.8 million for the corresponding three month period of 2020.

For Q4 2021, the company had an operating loss of $2.5 million compared to an op [Author ID1: at Fri Mar 25 12:54:00 2022 ]operating loss of $1 million for the comparable period is [Author ID1: at Fri Mar 25 12:54:00 2022 ]of[Author ID1: at Fri Mar 25 12:54:00 2022 ] [Author ID1: at Fri Mar 25 12:54:00 2022 ]2020. Adjusted EBITDA with [Author ID1: at Fri Mar 25 12:54:00 2022 ]was[Author ID1: at Fri Mar 25 12:54:00 2022 ] [Author ID1: at Fri Mar 25 12:54:00 2022 ]negative $2.3 million for Q4 2021 compared to $0.8 million for the same period last year.

The net comprehensive loss was $2.9 million or $0.02 on a basic and delete [Author ID1: at Fri Mar 25 12:54:00 2022 ]diluted[Author ID1: at Fri Mar 25 12:54:00 2022 ]*[Author ID1: at Fri Mar 25 12:54:00 2022 ] [Author ID1: at Fri Mar 25 12:54:00 2022 ]per share basis for Q4 2021, compared to net comprehensive loss of $1.2 million or one share [Author ID1: at Fri Mar 25 12:55:00 2022 ]-- [Author ID1: at Fri Mar 25 12:55:00 2022 ]$0.01 sorry,[Author ID1: at Fri Mar 25 12:55:00 2022 ] per share for the comparable period of 2020. Now let's look at the full year end of 2021.

Total revenues for the year end, December 31, 2021 amounted to $1.5 million. And this is consistent with the year end and the December 31, 2020.

Operating costs and expenses were $9.5 million for the 12 month period ended December 31, 2021 versus $7.8 million for the corresponding period of 2020. For the full year of 2021, the company and an operating loss of $8 million compared to an operating loss of $6.2 million for the comparable period of 2020.

Our net comprehensive loss for the year was $9.9 million or $0.07 per basic and diluted shares for the 12 months of 2021 compared to net comprehensive loss of $7.1 million or also $0.07, sorry, per share for the comparable period of 2020. As at December 31, 2021, the company's cash and short term investment totalled $9.9 million, which did not include the $3 million sicker [Author ID1: at Fri Mar 25 12:56:00 2022 ]secured*[Author ID1: at Fri Mar 25 12:56:00 2022 ] [Author ID1: at Fri Mar 25 12:56:00 2022 ]loan rented [Author ID1: at Fri Mar 25 12:56:00 2022 ]g[Author ID1: at Fri Mar 25 12:56:00 2022 ]r[Author ID1: at Fri Mar 25 12:56:00 2022 ]a[Author ID1: at Fri Mar 25 12:56:00 2022 ]nted[Author ID1: at Fri Mar 25 12:56:00 2022 ]*[Author ID1: at Fri Mar 25 12:56:00 2022 ] [Author ID1: at Fri Mar 25 12:56:00 2022 ]to IntelGenx by atai in February of 2022.

I would like to point out that a lot of the increase in the expenses is attributable to the fact that we received several Canadian government support programs related to COVID covering among other things, employee salary during 2020. On that, I will now turn the call back to Dr.

Zerbe. Horst?

Thanks Andre. In closing, I'd like to once again recognize our team for executing on our long term strategy.

And with that, I will now turn the call over for questions. I would like to remind you that our forward-looking statements apply to both our prepared remarks and to following Q&A.

Thank you.

Dr. Zerbe and Andre, I wanted to ask about this, Tilray arbitration.

Can you give us a little, information about the progress? Do you see this settling soon?

Hi, Anthony it's Horst here, and thanks for the question. We sure can.[Author ID1: at Fri Mar 25 13:00:00 2022 ],[Author ID1: at Fri Mar 25 13:00:00 2022 ] I will turn over to Tommy Kenny, our General Counsel, and he will comment on that.

Hi Anthony, thank you for your question. As you may know, the proceeding for the arbitration is confidential.

What you can reiterate is that we're very confident that the other [Author ID1: at Fri Mar 25 13:00:00 2022 ]alleged*[Author ID1: at Fri Mar 25 13:00:00 2022 ] [Author ID1: at Fri Mar 25 13:00:00 2022 ]breach of the agreement by Tilray will be proven in arbitration, but right now we're continuing the proceeding as with [Author ID1: at Fri Mar 25 13:00:00 2022 ]was[Author ID1: at Fri Mar 25 13:00:00 2022 ] [Author ID1: at Fri Mar 25 13:00:00 2022 ]announced to shareholder. We will be able to give you some more information when we have a closing of the proceeding when it's adjudicated or if there is a settlement between, but for now, there is not much we can say about the proceedings.

Okay. I have another question if I may.[Author ID1: at Fri Mar 25 13:01:00 2022 ],[Author ID1: at Fri Mar 25 13:01:00 2022 ]

Yeah, go ahead.

So Alzheimers, I know that we restarted the high dosage Alzheimers study. How long do you anticipate that it'll take to recruit and when do you believe we'll get results of this Alzheimers trial?

Yeah. Okay.

Thanks for the question, Anthony. So I think I mentioned, previously that enrolment has resumed after we had to put the study on hold you [Author ID1: at Fri Mar 25 13:03:00 2022 ]due*[Author ID1: at Fri Mar 25 13:03:00 2022 ] [Author ID1: at Fri Mar 25 13:03:00 2022 ]to the COVID situation.

We expect,[Author ID1: at Fri Mar 25 13:03:00 2022 ] the enrolment to be completed,[Author ID1: at Fri Mar 25 13:03:00 2022 ] let me see, in December of -- I'm sorry, in August of this year and then the last patient needs to be dozed for six months that will take us to approximately February of 2023. Then comes the data crunching.

So we expect final results from that study to be available by mid 2023 May, June.

Okay. Could you give us a little bit more information regarding your animal healthcare initiatives?

I know that the VersaFilm[Author ID1: at Fri Mar 25 13:04:00 2022 ] [Author ID1: at Fri Mar 25 13:04:00 2022 ]Ve[Author ID1: at Fri Mar 25 13:04:00 2022 ]t[Author ID1: at Fri Mar 25 13:04:00 2022 ]aFilm[Author ID1: at Fri Mar 25 13:04:00 2022 ]*[Author ID1: at Fri Mar 25 13:04:00 2022 ] [Author ID1: at Fri Mar 25 13:04:00 2022 ]was exciting news that, you had some good clinical results and have we made any progress on moving forward with the commercialization?

We sure have. Dana can, can[Author ID1: at Fri Mar 25 13:04:00 2022 ] comment on that because Dana has been maintaining the contract with the partner there.

Dana, can you please comment?

Of course. Hi Anthony.

So as you're correct, we're moving forward on our one contract with a US company on our beta [Author ID1: at Fri Mar 25 13:05:00 2022 ]Veta[Author ID1: at Fri Mar 25 13:05:00 2022 ]Film*[Author ID1: at Fri Mar 25 13:05:00 2022 ] platform. As you know this is a prescription program.

So we're manufacturing for another clinical trial some film[Author ID1: at Fri Mar 25 13:05:00 2022 ][Indiscernible][Author ID1: at Fri Mar 25 13:05:00 2022 ]. And after this, we will follow the regulatory proceedings.

So this is not something that's going to be launched tomorrow. It will take some time.

We need to do some additional trials. It's just a normal regulatory pathway but on the general animal health strategy right now, we did hire external help in end of Q4 last year.

We presented our VetaFilm platform to many animal health companies and three companies are at this moment actively evaluating our platform to see how it would fit within their pipeline and compounds to use our platform going forward.

Okay. So this is still, far in the distance as far as getting it on the market.

So more than like two, three years. Okay.

Yes, that's correct. Yes.

And,[Author ID1: at Fri Mar 25 13:06:00 2022 ] tell us about the psychedelics. So we were excited about the atai relationship and I know that atai has a couple of two or three compounds for psychedelics and, can you give us any progress on that?

[Author ID1: at Fri Mar 25 13:06:00 2022 ] [End][Author ID1: at Fri Mar 25 13:06:00 2022 ] [Author ID2: at Fri Mar 25 18:23:00 2022 ] [Author ID0: at Thu Nov 30 00:00:00 1899 ] [Author ID0: at Thu Nov 30 00:00:00 1899 ] [Author ID2: at Fri Mar 25 18:23:00 2022 ]

Yeah. [Author ID2: at Fri Mar 25 18:29:00 2022 ]Dana you want to comment?

You're sure knows [Author ID2: at Fri Mar 25 18:29:00 2022 ]those clinical…[Author ID2: at Fri Mar 25 18:29:00 2022 ].[Author ID2: at Fri Mar 25 18:29:00 2022 ]

Sure. [Author ID2: at Fri Mar 25 18:29:00 2022 ]Yeah, of course I can.

My pleasure. So for the psychedelics program, so one of them we're manufacturing right now, the GMP product for the clinical supply.

There is the clinical program is going to be head overseas. So there has to be some,[Author ID2: at Fri Mar 25 18:30:00 2022 ] permits being exchanged at this moment, but everything is on track to run the clinical trial and on our end, our obligation is to submit those samples or the film [Author ID2: at Fri Mar 25 18:30:00 2022 ]support of [Author ID2: at Fri Mar 25 18:31:00 2022 ]firms for the [Author ID2: at Fri Mar 25 18:31:00 2022 ]clinical space[Author ID2: at Fri Mar 25 18:31:00 2022 ]site[Author ID2: at Fri Mar 25 18:31:00 2022 ].

So we're almost done with one project, at least for that stage. And for the other one, we're for it [Author ID2: at Fri Mar 25 18:32:00 2022 ][indiscernible][Author ID2: at Fri Mar 25 18:32:00 2022 ] [Author ID2: at Fri Mar 25 18:32:00 2022 ]we're starting right now on the formulation optimization so that we also can manufacture then and [Author ID2: at Fri Mar 25 18:32:00 2022 ]a clinically trial sample for a clinical trial.

And in addition, we are in discussion on other programs on this [Author ID2: at Fri Mar 25 18:33:00 2022 ]with our partner.

In the psychedelic space or some other space?

No, in the psychedelic space.

Okay. Tell us about Tadalafil.

Are we getting close to a product that's gonna[Author ID2: at Fri Mar 25 18:33:00 2022 ]going to [Author ID2: at Fri Mar 25 18:33:00 2022 ] be commercialized?

So you broke off Anthony. Can you please repeat?

Okay. So to Tadalafil, are we getting closer to commercialization of the thin film version of Tadalafil?

Yes. So, I can answer that as well.

So as you know, this is a partner program with Aquestive where both companies are responsible for preparing the answers for the CRA that the product has received. There is, we're preparing right now, some studies to answer the CRA.

It's all underway.[Author ID2: at Fri Mar 25 18:34:00 2022 ] We're [Author ID2: at Fri Mar 25 18:34:00 2022 ]where [Author ID2: at Fri Mar 25 18:34:00 2022 ]within the timeline that we are to[Author ID2: at Fri Mar 25 18:34:00 2022 ]also[Author ID2: at Fri Mar 25 18:34:00 2022 ] communicated to our commercial partner and we're expecting that the product,[Author ID2: at Fri Mar 25 18:35:00 2022 ] will be submitted to the FDA for review later this year. And then, hopefully soon, early next year we were going to see the product being approved and then launch preparation to happen.

Early in 2023. Okay.

Yes.

Okay. And, tell me, so this is really for Andre.

I see that we have some debt maturing this year in 2022. Are we, how do we handle the maturities?

Well, [Author ID2: at Fri Mar 25 18:35:00 2022 ]Some of,[Author ID2: at Fri Mar 25 18:35:00 2022 ] about 25%, 30% has already been converted,[Author ID2: at Fri Mar 25 18:36:00 2022 ] of this debenture maturing in June and obviously we're hoping that,[Author ID2: at Fri Mar 25 18:36:00 2022 ] some more can be converted, but based on the share price right now, the conversion is about $0.40. So if we don't get converted, we have two options to reimburse it in cash or in share.

So, the option at that moment would probably be to pay it in cash, but the decision hasn’t been final yet.

Okay. That's all I have.

Yes. Good afternoon.

Thanks for taking my question. It's Latin, by the way.

That's okay though. Your previous person also [Author ID2: at Fri Mar 25 18:37:00 2022 ]answer [Author ID2: at Fri Mar 25 18:37:00 2022 ]asked a couple of my questions, but one question I did have was, could you give us some information about how things are going with the migraine sales in Europe because we haven't heard anything and a little bit of news, if it's good would help?

That would again be di [Author ID2: at Fri Mar 25 18:37:00 2022 ]Dana.

Yeah, my pleasure. So our commercial partner Exeltis in Spain, sees a very good trend of the product.

We had a sales meeting at the end of the year and the product is certainly getting traction. The[Author ID2: at Fri Mar 25 18:38:00 2022 ]they're[Author ID2: at Fri Mar 25 18:38:00 2022 ] launching a great campaign to really push the marketing and going out with a really nice promotion.

[Author ID2: at Fri Mar 25 18:38:00 2022 ][Author ID0: at Thu Nov 30 00:00:00 1899 ] [Author ID2: at Fri Mar 25 18:38:00 2022 ] At this moment we're waiting for, it's still early days there. They're launch in September and the beginning you usually wait for a little bit, but so far the traction is great.

They,[Author ID2: at Fri Mar 25 18:38:00 2022 ] really get a nice percentage of the market and, it's all very hopeful. So that's as much as much [Author ID2: at Fri Mar 25 18:39:00 2022 ]as I can say.

Okay. So you can't provide any kind of numbers or what it added to your revenue or anything like any detail?

No, it's too early. We are receiving royalty of the product.

So, and royalties, it will take a bit, but…

Okay. Early [Author ID2: at Fri Mar 25 18:39:00 2022 ]Any progress on moving into other countries?

I know there are things going on in Europe right now, but have there been any discussions about expanding your market?

Yes, we are in fact a [Author ID2: at Fri Mar 25 18:39:00 2022 ]scheduled to discuss the global reach and to other markets within Europe. So I do have a card set up that they're global head of business development to really discuss the strategies and which markets they're going to go next.

Certainly there is going to be a regulatory strategy behind because the product is approved in Spain and there are different ways to get it approved in the additional markets. But yes, that's certainly the goal.

Okay. Very good.

So there's progress there in other words, and thank you. That's good news.

The other question I had, regarding CBD strips, again, we haven't heard anything since the summer. So six months ago, or more than six months ago now, since you made your last shipment.

Any more business happening there or is that kind of quiet?

Horst, do you want me to answer that question?

Yeah, yeah, you should.

Okay. so for the cannabis franchise, we are really exploring now, additional markets.

As you know, Canada has a very unique regulatory framework to yes, [Author ID2: at Fri Mar 25 18:41:00 2022 ]that allows company to market and launch cannabis film, which is not the same in, let's say Europe. So we were working with regulatory experts to see how we can export into other markets and what it would take to make our product fit into these categories.

But, there is a strong interest for example, Germany where, cannabis is allowed to import our product there and we're working on this [Author ID2: at Fri Mar 25 18:42:00 2022 ]very actively. So there will be some progress coming.

So that's good. Thank you.

That's good news as well, but nothing imminent here in Canada or there's nothing sort of coming quickly. It's just it you're working on it.

Is that where you're at?

That's correct. Yes.

Okay. Very good.

If I could just make comment and to everybody, and I don't know how you're going to react to this. There's been a lot of silence from management to the market since, well, really over the last six months we haven't heard much of anything from you.

Would it be possible to keep your shareholders and the market's up to date a little bit more effectively. Your Investor Relations person doesn't do anything.

No offense. If he's on the call.

We don't hear anything. There's just,[Author ID2: at Fri Mar 25 18:43:00 2022 ] -- [Author ID2: at Fri Mar 25 18:43:00 2022 ]there's no news and yours, a very news driven stock.

Let's not get [Author ID2: at Fri Mar 25 18:43:00 2022 ]repeat[Author ID2: at Fri Mar 25 18:43:00 2022 ] [Author ID2: at Fri Mar 25 18:43:00 2022 ]ourselves. Would it be possible to improve the flow of information because it [Author ID2: at Fri Mar 25 18:43:00 2022 ]sounds like you have a lot to say.

We have weekly meetings to discuss shareholder communication. We take that very seriously.

We don't want to, get on a path that just in order to be heard.[Author ID2: at Fri Mar 25 18:44:00 2022 ] W[Author ID2: at Fri Mar 25 18:44:00 2022 ]w[Author ID2: at Fri Mar 25 18:44:00 2022 ]e come out with irrelevant or a nonsense information like and [Author ID2: at Fri Mar 25 18:44:00 2022 ]some companies apparently prefer to do. That is not really our style.

So we try to publish information that is really material and of value for investors to be heard. That's our general policy.

So there are at times stretches where while we are extremely active in our business development activities and here in the lab, that there is just not that the information has not just advanced to the point that we can come out with meaningful information. So that's why, we see at times stretches where we,[Author ID2: at Fri Mar 25 18:45:00 2022 ] have to remain silent for the reasons that as I explained before, but that doesn't mean that things are not happening.

Things are happening. We just wait for the trigger moments and events, but we hear you loudly and clearly, and we will certainly make every effort to keep investors informed to the best of our ability.

Yes. Thank you for taking my call.

My first question is regarding the migraine following with the FDA filing, I'm sorry, with the FDA. I believe it was supposed to be complete first quarter 2022.

Where are you with this? And has there been problems,[Author ID2: at Fri Mar 25 18:46:00 2022 ] whether [Author ID2: at Fri Mar 25 18:46:00 2022 ]while [Author ID2: at Fri Mar 25 18:46:00 2022 ]there's a delay?

We manufactured three full scale batches as required by FDA to respond to the complete response letter. These three batches are currently in stability testing.

We plan to contact FDA by midyear for to apply for meeting, to then discuss details of the response. So, you're right.

Quite some time ago, we were under the impression that we could respond earlier this year. Unfortunately the, manufacturing of these batches, have stretched out a little more mostly because we were in conflicts in our manufacturing operation with BELBUCA manufacturing, which was quite time consuming.

So there has been, we have to admit that there has been a slight delay, but the batch is happy manufactured, they look good,[Author ID2: at Fri Mar 25 18:48:00 2022 ] stability testing so far gives us a very promising results. So we are moving forward there.

So you're thinking submission would occur second half of this year and then take another six months. So we'd be looking at the earliest approval being January 2023.

I think January 2023 would be challenging. It would be 2023, but I think more towards, midyear.

Dana, do you recall the more specific dates?

Yeah, so right now I think the plan is that we're going to have a six month review and that would bring us into early 2023 kind of mid to early 2023 somewhere there. Summer 2023 I think that's the most we can say at this moment there.

We still have to meet with the FT[Author ID2: at Fri Mar 25 18:49:00 2022 ]D[Author ID2: at Fri Mar 25 18:49:00 2022 ]A. There are a couple of unknown items, which we don't know how to impact the timeline.

And based on that our current prediction is that we will have an approved product by the summer next year.

I'm sure we all agree. It's about time that this thing gets moving.

The cash was very disturbing last year. Do we see that be[Author ID2: at Fri Mar 25 18:50:00 2022 ]coming -- do we see that minimizing and from this call, it doesn't seem like there's much revenue going to be affecting this year on the horizon.

Andre, can you give us some insight into how you see the cash burn increasing, decreasing stabilizing, and what kind of revenue might we expect this year because I'm not hearing very much.

Yeah, we try to control our spending. Obviously the [Author ID2: at Fri Mar 25 18:50:00 2022 ]last year we add a lot of support from the Kenyan [Author ID2: at Fri Mar 25 18:51:00 2022 ]Canadian [Author ID2: at Fri Mar 25 18:51:00 2022 ]Government, like I said, which obviously was reduced our cash burn.

But, we're trying to stay very tight and, minimize spending. But, as we mentioned, we are looking to launch, a couple of products next year.

So we need to be commercial ready. So which means we need to hire, few people [Author ID2: at Fri Mar 25 18:51:00 2022 ]in the back in the manufacturing, because we might be, maybe not around the clock, but depending on the volume, we could be very [Author ID2: at Fri Mar 25 18:52:00 2022 ]busy in the back.

So, apart from that, I don't see any substantial expenditure on our end because we like I said, we keep everything very tight. In terms of revenue, we're hoping that for 2022, we'll have R&D revenue obviously, and hopefully cannabis and RIZAPORT, we haven't disclosed yet, or because we haven't received a report from our commercial partner in Spain, but we will be disclosing some royalty in the next quarter and from that, it should continue every, every [Author ID2: at Fri Mar 25 18:53:00 2022 ]quarter.

[Author ID2: at Fri Mar 25 18:53:00 2022 ][Author ID0: at Thu Nov 30 00:00:00 1899 ] [Author ID2: at Fri Mar 25 18:53:00 2022 ] The launch app as mentioned -- [Author ID2: at Fri Mar 25 18:53:00 2022 ]as Dana mentioned in September. So, by year end, there's about 90 days before we get our royalty payment.

So it will be in Q2 and then we'll get recurrent revenue coming from RIZAPORT in Spain, but we're working very hard trying to obviously increase revenue, near term revenue and, like I said earlier, 2023, hopefully we'll have revenue increase.

Good afternoon, everyone. Thank you for allowing me to speak here today, but I have two questions in regards to the BUENA trial, I know there was a re [Author ID2: at Fri Mar 25 18:54:00 2022 ]commencement.

My specific question is that how many total patients are enrolled at the moment and how many have been enrolled since the recommencement[Author ID2: at Fri Mar 25 18:54:00 2022 ]s[Author ID2: at Fri Mar 25 18:55:00 2022 ] [Author ID2: at Fri Mar 25 18:54:00 2022 ]recommitment[Author ID2: at Fri Mar 25 18:54:00 2022 ] [Author ID2: at Fri Mar 25 18:54:00 2022 ]of this trial.

In total, I believe we're right now at around [Author ID2: at Fri Mar 25 18:55:00 2022 ]35 or 36 in that neighborhood. And since we raised enrolment one patient has been -- [Author ID2: at Fri Mar 25 18:55:00 2022 ]has, has [Author ID2: at Fri Mar 25 18:55:00 2022 ]commenced treatment and two are now nearing the end of the evaluation and then should go on treatment.

Okay. Not part of -- Oh, I'm sorry.

Right now to give you a broader picture that with the sites that we have and the commitment that we will enrol one patient per month per site that the full enrol [Author ID2: at Fri Mar 25 18:56:00 2022 ]enrolment will have completed by August.

Okay. A follow up to that is what do the numbers [Author ID2: at Fri Mar 25 18:56:00 2022 ]nbers [Author ID2: at Fri Mar 25 18:56:00 2022 ]need to treat to achieve any sort of clinical significance?

I'm sorry. I did.

I missed that acoustically. Can you please repeat?

Yeah[Author ID2: at Fri Mar 25 18:56:00 2022 ].

What is the num[Author ID2: at Fri Mar 25 18:57:00 2022 ]ber needed to treat,[Author ID2: at Fri Mar 25 18:57:00 2022 ] to achieve some sort of clinical significance?

The study has been populated, so that based on the pretrial stats that we were running we can assume that we will have sufficient power to make a statement regarding efficacy.

And, just to…

Clarify with this [Author ID2: at Fri Mar 25 18:57:00 2022 ]with the 70 patients; we believe the study has been sufficiently powered.

Thank you for that.

Yes. Good afternoon, everyone.

And thank you for taking my call. Some of my questions have been answered, but I'd like to start with the VISPO [Author ID2: at Fri Mar 25 19:05:00 2022 ][ [Author ID2: at Fri Mar 25 19:04:00 2022 ]ph] you'll h ave to say [Author ID2: at Fri Mar 25 19:06:00 2022 ]the are you allowed to say [Author ID2: at Fri Mar 25 19:06:00 2022 ]when the end date will be done on the facility?

Excuse me, stability testing. I know the batches were manufactured, but may have been a hiccup, but any idea when the six months will end?

The six months will end around mid-year for, let's say for the last batch.[Author ID2: at Fri Mar 25 19:07:00 2022 ] For the first batch, the six months will end around April and then, second batch a little later. And, and third batch around June, if I recall correctly.

Yeah.

Okay. That's a good time frame.

And then may [Author ID2: at Fri Mar 25 19:07:00 2022 ]that maybe [Author ID2: at Fri Mar 25 19:07:00 2022 ]you start [Author ID2: at Fri Mar 25 19:08:00 2022 ]op [Author ID2: at Fri Mar 25 19:08:00 2022 ]making inroad for the next meeting with the FDA? From the end, the stability you, you reach out to see if you can have a sit down session?[Author ID2: at Fri Mar 25 19:08:00 2022 ]

Yes. From the end, the stability you reach out to see if you can have sit down session?[Author ID2: at Fri Mar 25 19:08:00 2022 ]We're,[Author ID2: at Fri Mar 25 19:09:00 2022 ] Once we have sufficient data, that will be actually couple months before we completed the six months data for the third batch, we'll reach out to FDA to apply for a meeting to discuss filing strategy.

Okay. That's [Author ID2: at Fri Mar 25 19:10:00 2022 ]Thank you for that one.

And Tadafill[Author ID2: at Fri Mar 25 19:15:00 2022 ] [Author ID2: at Fri Mar 25 19:15:00 2022 ]data flow[Author ID2: at Fri Mar 25 19:12:00 2022 ] [Author ID2: at Fri Mar 25 19:15:00 2022 ]on the irritation study is end date of that. I know you said it was eight; it [Author ID2: at Fri Mar 25 19:12:00 2022 ]takes about eight months for that's[Author ID2: at Fri Mar 25 19:12:00 2022 ] the [Author ID2: at Fri Mar 25 19:12:00 2022 ]irritation study with that end by the end of June?

Dana, do you want to comment you, you [Author ID2: at Fri Mar 25 19:12:00 2022 ]are in your [Author ID2: at Fri Mar 25 19:12:00 2022 ]dialogue with requested[Author ID2: at Fri Mar 25 19:12:00 2022 ] [Author ID2: at Fri Mar 25 19:12:00 2022 ]Aquestive[Author ID2: at Fri Mar 25 19:12:00 2022 ]?

Yeah, absolutely. So at this moment the irritation study hasn't started because we had to make sure that we have the right people and that we're following the protocol that we discussed with the FDA.

The plan is to start [Author ID2: at Fri Mar 25 19:13:00 2022 ]in April.[Author ID2: at Fri Mar 25 19:13:00 2022 ] There [Author ID2: at Fri Mar 25 19:13:00 2022 ]at [Author ID2: at Fri Mar 25 19:13:00 2022 ]had to be new batch manufacturers. So we had to be conscious about that and getting the time of [Author ID2: at Fri Mar 25 19:13:00 2022 ]the CRO[ph][Author ID2: at Fri Mar 25 19:13:00 2022 ] to have patients ready.

So the, the [Author ID2: at Fri Mar 25 19:13:00 2022 ]current plan is to start the study in April.

So, in April eight months from there, we'll hopefully get an update. All right.

And regarding to Tadafill[Author ID2: at Fri Mar 25 19:15:00 2022 ] [Author ID2: at Fri Mar 25 19:15:00 2022 ]that to Dallas[Author ID2: at Fri Mar 25 19:15:00 2022 ], or [Author ID2: at Fri Mar 25 19:15:00 2022 ]I know you [Author ID2: at Fri Mar 25 19:15:00 2022 ]you've entered agreement with the US commercialization partner, any discussions going on for other countries worldwide,

Their capabilities are really for the US market and, and [Author ID2: at Fri Mar 25 19:15:00 2022 ]that's what we partnered with them for.

Is there any discussions with anyone else [Author ID2: at Fri Mar 25 19:16:00 2022 ]they were out [Author ID2: at Fri Mar 25 19:16:00 2022 ]any other [Author ID2: at Fri Mar 25 19:16:00 2022 ]of the [Author ID2: at Fri Mar 25 19:16:00 2022 ]interested parties?

Of course, yes. Actually in fact Horst[Author ID2: at Fri Mar 25 19:16:00 2022 ] [Author ID2: at Fri Mar 25 19:16:00 2022 ]horse[Author ID2: at Fri Mar 25 19:16:00 2022 ] and I just came back from a partnering conference where I had nervous discussions about European rights for this product.

So we're going to do our follow up and then see if, if [Author ID2: at Fri Mar 25 19:17:00 2022 ]those partners have the commercial capabilities to really support what [Author ID2: at Fri Mar 25 19:17:00 2022 ]our [Author ID2: at Fri Mar 25 19:17:00 2022 ]program.

Okay. Thank you for that, Dana.

And just Dana, one of the questions I my connection was little weak, but right now we have agreements for with two animal healthcare companies. First one, January 20 and another one this year, this past year.

Is that accurate?

That is accurate. Yes.

And, and [Author ID2: at Fri Mar 25 19:17:00 2022 ]did I hear and correct me if I didn't hear it properly, you[Author ID2: at Fri Mar 25 19:17:00 2022 ]you're [Author ID2: at Fri Mar 25 19:17:00 2022 ] [Author ID2: at Fri Mar 25 19:17:00 2022 ]in discussion with a host more of other veterinarian companies?

Yes. Yes, we are.

We sent out our sample to evaluating,[Author ID2: at Fri Mar 25 19:18:00 2022 ] it is a new technology. So the concept is different than giving a tablet.

So a lot of companies have an interest in seeing how certainly the firm would work in an animate setting. They want to see it for themselves, so they [Author ID2: at Fri Mar 25 19:18:00 2022 ]they're testing it and we would see what comes out of it and which programs would fit onto that platform.

But yes, we are o[Author ID2: at Fri Mar 25 19:19:00 2022 ]i[Author ID2: at Fri Mar 25 19:19:00 2022 ]n the [Author ID2: at Fri Mar 25 19:19:00 2022 ]discussions with several companies.

Okay. And last question is on the, the [Author ID2: at Fri Mar 25 19:19:00 2022 ]big Heritage Georgia [Author ID2: at Fri Mar 25 19:20:00 2022 ]that was talked about in the third quarter call[Author ID2: at Fri Mar 25 19:20:00 2022 ], qu is [Author ID2: at Fri Mar 25 19:20:00 2022 ]was [Author ID2: at Fri Mar 25 19:20:00 2022 ]that progressing order?

Is that so [Author ID2: at Fri Mar 25 19:20:00 2022 ]on storage?

Everything has been shipped.

Everything has been shipped. All right.

And, I think that completes my questions. I'll go back into queue.

Hey, how are you guys doing today? Thank you so much for taking my question.

or question [Author ID2: at Fri Mar 25 19:22:00 2022 ]So the one I want to leave with was about Heritage. So if all the Heritage orders had shipped, shouldn't that have reflected more significantly on the book?[Author ID2: at Fri Mar 25 19:22:00 2022 ] The small order was about $[Author ID2: at Fri Mar 25 19:22:00 2022 ]75,000[Author ID2: at Fri Mar 25 19:22:00 2022 ] K [Author ID2: at Fri Mar 25 19:22:00 2022 ]in revenue?[Author ID2: at Fri Mar 25 19:22:00 2022 ] and you guys said that you shipped had [Author ID2: at Fri Mar 25 19:23:00 2022 ]out a[Author ID2: at Fri Mar 25 19:23:00 2022 ]a, a [Author ID2: at Fri Mar 25 19:23:00 2022 ] [Author ID2: at Fri Mar 25 19:23:00 2022 ]much larger order.

Can you guys give any clarity on that?

Dana, can you comment?

You, [Author ID2: at Fri Mar 25 19:23:00 2022 ]I think it's more financial statement problem. I think the orders were shipped.

I think when the invoices get paid, I, [Author ID2: at Fri Mar 25 19:23:00 2022 ]I would refer to Andre, but we, we [Author ID2: at Fri Mar 25 19:23:00 2022 ]shipped everything out and there's certainly are some royalties [Author ID2: at Fri Mar 25 19:24:00 2022 ]art, sob [Author ID2: at Fri Mar 25 19:23:00 2022 ]varieties [Author ID2: at Fri Mar 25 19:24:00 2022 ]due, which are[Author ID2: at Fri Mar 25 19:24:00 2022 ] royalty [Author ID2: at Fri Mar 25 19:24:00 2022 ]variety [Author ID2: at Fri Mar 25 19:24:00 2022 ]report is in the progress right now. Again[Author ID2: at Fri Mar 25 19:24:00 2022 ]A[Author ID2: at Fri Mar 25 19:24:00 2022 ]ndre[Author ID2: at Fri Mar 25 19:24:00 2022 ], we [Author ID2: at Fri Mar 25 19:24:00 2022 ]explained already that a lot of those contracts, there's a certain period after the quarter closes where the company's prepared the Royal reports and then pay.

So this is all in the progress, but yes, you would see something reflected soon.

Okay, awesome. I appreciate that.

Also, alright, so my next question is going to be specifically about the me[Author ID2: at Fri Mar 25 19:25:00 2022 ] [Author ID2: at Fri Mar 25 19:25:00 2022 ].[Author ID2: at Fri Mar 25 19:25:00 2022 ]--[Author ID2: at Fri Mar 25 19:25:00 2022 ] all right. So did you guys, I was, when I was listening earlier, did you mention Sabin [Author ID2: at Fri Mar 25 19:26:00 2022 ][indiscernible][Author ID2: at Fri Mar 25 19:26:00 2022 ] [Author ID2: at Fri Mar 25 19:26:00 2022 ]or was I hearing things?

No, we didn't I didn't mention Cybin[Author ID2: at Fri Mar 25 19:29:00 2022 ] [Author ID2: at Fri Mar 25 19:29:00 2022 ]Sabin [Author ID2: at Fri Mar 25 19:29:00 2022 ] [Author ID2: at Fri Mar 25 19:27:00 2022 ]in the [Author ID2: at Fri Mar 25 19:26:00 2022 ]in my introductory remarks.

No. Okay.

Sorry[Author ID2: at Fri Mar 25 19:27:00 2022 ] about that. Okay.

No problem. So that brings me in[Author ID2: at Fri Mar 25 19:27:00 2022 ]to my [Author ID2: at Fri Mar 25 19:27:00 2022 ]that [Author ID2: at Fri Mar 25 19:27:00 2022 ]next question.

So you explain how that you were going to work on more psychedelic formulations, who I'm assuming [Author ID2: at Fri Mar 25 19:28:00 2022 ]assist [Author ID2: at Fri Mar 25 19:28:00 2022 ]with Atai[Author ID2: at Fri Mar 25 19:28:00 2022 ]is with a tie[Author ID2: at Fri Mar 25 19:28:00 2022 ]. So we know right now the two things you're working on,[Author ID2: at Fri Mar 25 19:28:00 2022 ] or we don't know we're speculating is DMT [ph] and Cybin related.

Could you give us any insight on what other psychedelic medicines you might be working on and can you and it's going to be with Atai. [Author ID2: at Fri Mar 25 19:30:00 2022 ]a, [Author ID2: at Fri Mar 25 19:30:00 2022 ]Can you give a yes or no about that?

We currently have two active programs. You mentioned the, the [Author ID2: at Fri Mar 25 19:30:00 2022 ]compounds and we are in discussions for a third one.

And I think commencement of that program is more or less imminent. And so with that, we would then have three programs in active development.

What comes afterwards?[Author ID2: at Fri Mar 25 19:30:00 2022 ] we don't know yet.[Author ID2: at Fri Mar 25 19:30:00 2022 ] There will be more, I mean, [Author ID2: at Fri Mar 25 19:30:00 2022 ]we have a very long list of candidates from them. Several doesn’t,[Author ID2: at Fri Mar 25 19:31:00 2022 ] comment bit[Author ID2: at Fri Mar 25 19:31:00 2022 ], which one will be next.

We can say.[Author ID2: at Fri Mar 25 19:31:00 2022 ] They[Author ID2: at Fri Mar 25 19:31:00 2022 ] Today[Author ID2: at Fri Mar 25 19:31:00 2022 ], they haven't discussed that yet with us.

Very welcome, man. [Author ID2: at Fri Mar 25 19:31:00 2022 ]I appreciate you guys very much in closing what I say also that if you guys are [Author ID2: at Fri Mar 25 19:31:00 2022 ]or[Author ID2: at Fri Mar 25 19:31:00 2022 ] [Author ID2: at Fri Mar 25 19:31:00 2022 ]Dana or any,[Author ID2: at Fri Mar 25 19:32:00 2022 ] one of you would ever want to do a Q&A,[Author ID2: at Fri Mar 25 19:32:00 2022 ] I [Author ID2: at Fri Mar 25 19:32:00 2022 ]would love to do one with you guys, and it would be an easy way for you guys to get some more exposure if you that's what you want to do.

Because I heard a caller mentions that earlier. I just want to throw that out there.

So thank you for very much and I appreciate you guys.

Good afternoon, everyone. I, [Author ID2: at Fri Mar 25 19:32:00 2022 ]I think I heard earlier, you said that part of the delay in manufacturing, RIZAPORT batch is, was because you were I guess manufacturing, Belbuca[Author ID2: at Fri Mar 25 19:33:00 2022 ]beca is that[Author ID2: at Fri Mar 25 19:33:00 2022 ], is that accurate?

That is correct. Yeah.

So would you expect any revenue from that or what?

We, we [Author ID2: at Fri Mar 25 19:34:00 2022 ]can't comment on that. I'm sorry.

So I get strict instructions from legal that we are obligated to remain silent on the status of, of [Author ID2: at Fri Mar 25 19:34:00 2022 ]that program.

Okay. And then back to the heritage, I think last caller mentioned on the, the [Author ID2: at Fri Mar 25 19:34:00 2022 ]revenues and, and [Author ID2: at Fri Mar 25 19:34:00 2022 ]you all had said that I guess the sales reports or [Author ID2: at Fri Mar 25 19:34:00 2022 ], or [Author ID2: at Fri Mar 25 19:34:00 2022 ]quarterly reports weren't in or whatever, but wouldn't you, [Author ID2: at Fri Mar 25 19:34:00 2022 ]when you receive the manufacturing portion of that revenue soon after it's [Author ID2: at Fri Mar 25 19:35:00 2022 ]delivered,

Are we talking about CBD now?

Yes. Heritage.

Yeah. They all didn't [Author ID2: at Fri Mar 25 19:35:00 2022 ]didn [Author ID2: at Fri Mar 25 19:35:00 2022 ]accounted for, [Author ID2: at Fri Mar 25 19:35:00 2022 ].[Author ID2: at Fri Mar 25 19:35:00 2022 ] [Author ID2: at Fri Mar 25 19:35:00 2022 ]So they all didn't accounted for in our financial statement.

So I think that we recorded some in Q4 and some in Q1 for a [Author ID2: at Fri Mar 25 19:35:00 2022 ]total of roughly about a hundred thousand[Author ID2: at Fri Mar 25 19:35:00 2022 ]$100,000[Author ID2: at Fri Mar 25 19:35:00 2022 ].

So even the large order has been accounted for in the 2021 financials?

I don't know what, what [Author ID2: at Fri Mar 25 19:36:00 2022 ]you mean by large order, but…[Author ID2: at Fri Mar 25 19:36:00 2022 ]

You all had a small order.[Author ID2: at Fri Mar 25 19:36:00 2022 ] And then you said you [Author ID2: at Fri Mar 25 19:36:00 2022 ]You all [Author ID2: at Fri Mar 25 19:36:00 2022 ]had a smaller order. And then you said you had a, a [Author ID2: at Fri Mar 25 19:36:00 2022 ]follow up with a larger[Author ID2: at Fri Mar 25 19:36:00 2022 ] order that was in storage and it's now been shipped.

So are you saying that that's been accounted for?

Yeah, that's been accounted for, yeah.

Okay.

But we haven't received the royalty yet, but the manufacturing revenue has been accounted for.

Okay. And one last question.

So back to what another call was saying, it seems like there's probably, it doesn't appear that there's a lot of, of [Author ID2: at Fri Mar 25 19:37:00 2022 ]revenue in line for 2022, except possibly I guess, RIZAPORT, which we don't know how much that is. Do you, do you [Author ID2: at Fri Mar 25 19:37:00 2022 ] [Author ID2: at Fri Mar 25 19:37:00 2022 ]foresee, you've got enough capital to get you through mid-2023 when some of the programs mature and start generating revenue?

Yes. This is what the intent is.

So we're basically, okay. For the[Author ID2: at Fri Mar 25 19:38:00 2022 ],[Author ID2: at Fri Mar 25 19:38:00 2022 ] for at least another 12 to 15 months at which point we will be generating revenue.

So we, we [Author ID2: at Fri Mar 25 19:38:00 2022 ]don't see the necessity of raising money unless it would be for specific opportunity, but for the burn rate, we're fine.

Okay, good. I guess from what I'm hearing RIZAPORT, Tadalafil, Tadalafil[Author ID2: at Fri Mar 25 19:38:00 2022 ] [Author ID2: at Fri Mar 25 19:38:00 2022 ]won't be even if they're approved mid-2023, I mean,[Author ID2: at Fri Mar 25 19:38:00 2022 ] we're really not going to start seeing much revenue till wider part of 2023.

Is that accurate?

Yes, we [Author ID2: at Fri Mar 25 19:39:00 2022 ]we're expecting, like I said earlier to launch two new pro [Author ID2: at Fri Mar 25 19:39:00 2022 ]projects[Author ID2: at Fri Mar 25 19:39:00 2022 ] and programs[Author ID2: at Fri Mar 25 19:39:00 2022 ] in 2023 and Tadalafil[Author ID2: at Fri Mar 25 19:39:00 2022 ] [Author ID2: at Fri Mar 25 19:39:00 2022 ]Al [Author ID2: at Fri Mar 25 19:39:00 2022 ]might be a, [Author ID2: at Fri Mar 25 19:39:00 2022 ]the third one depending on the outcome of the irritation study and the time [Author ID2: at Fri Mar 25 19:39:00 2022 ]line of the irritation study,[Author ID2: at Fri Mar 25 19:39:00 2022 ].[Author ID2: at Fri Mar 25 19:39:00 2022 ]

What are the, excuse me, what are the other two besides Tadalafil[Author ID2: at Fri Mar 25 19:39:00 2022 ] [Author ID2: at Fri Mar 25 19:39:00 2022 ]co lot people[Author ID2: at Fri Mar 25 19:39:00 2022 ], maybe I'm missing one or?

RIZAPORT[Author ID2: at Fri Mar 25 19:40:00 2022 ] [Author ID2: at Fri Mar 25 19:40:00 2022 ]For [Author ID2: at Fri Mar 25 19:40:00 2022 ]US and the other one we cannot disclose.

Okay. So there's an undisclosed project that you feel is going to launch in early 2020

Potentially launch in 2023. Yes.

Okay. Thank you all.

You're welcome.

Hello and good afternoon. I have kind of a blast in the past item to ask about it may its cash [Author ID2: at Fri Mar 25 19:41:00 2022 ]cap [Author ID2: at Fri Mar 25 19:41:00 2022 ]flow.

So hopefully, I don't know, there's something there, but I doubt.[Author ID2: at Fri Mar 25 19:41:00 2022 ] Back when you guys told the Forfivo XL[Author ID2: at Fri Mar 25 19:42:00 2022 ]ForfivoXL[Author ID2: at Fri Mar 25 19:42:00 2022 ] royalty stream,[Author ID2: at Fri Mar 25 19:42:00 2022 ] as I understood it, there was a potentially significant milestone possibility something like $[Author ID2: at Fri Mar 25 19:42:00 2022 ]23 million or something like that of potential milestones of which IntelGenx would have the rights to 65%. Can you, it, it [Author ID2: at Fri Mar 25 19:43:00 2022 ]doesn't seem like that's happening or has ever [Author ID2: at Fri Mar 25 19:43:00 2022 ]will, will [Author ID2: at Fri Mar 25 19:43:00 2022 ]happen.

I'm just wondering if you can clarify for us whatever happened with those four, [Author ID2: at Fri Mar 25 19:43:00 2022 ]both milestones? Thank you.

Yeah. Or [Author ID2: at Fri Mar 25 19:43:00 2022 ]I can answer that.

Yes. I mean, [Author ID2: at Fri Mar 25 19:43:00 2022 ]There was several milestones that were that were [Author ID2: at Fri Mar 25 19:43:00 2022 ]possible for us to receive after we monetize the asset.

But unfortunately those milestones were based on achieving certain level of sales and those lever [Author ID2: at Fri Mar 25 19:44:00 2022 ]levels were, were [Author ID2: at Fri Mar 25 19:44:00 2022 ]not met. So unfortunately, even though we were entitled to receive them, if those level of sales would've been met, it, it [Author ID2: at Fri Mar 25 19:44:00 2022 ]never did.

So that's why we didn't get any of those milestones.

Okay. Is that something you're still tracking or is it considered dead at this point?

No, it is dead because it was per year and the levels of those sales [Author ID2: at Fri Mar 25 19:44:00 2022 ]cells [Author ID2: at Fri Mar 25 19:44:00 2022 ]needed to be met let's say the year after we monetized and the following year. So there was two potential milestones that we could receive two years after we monetized[Author ID2: at Fri Mar 25 19:45:00 2022 ] the assets.

But after that, there was no longer any milestone that could,[Author ID2: at Fri Mar 25 19:45:00 2022 ] we could receive. So it's, gone.

Okay. Well, it's [Author ID2: at Fri Mar 25 19:45:00 2022 ]-- it seems that the timing of the monetization was Sweden.[Author ID2: at Fri Mar 25 19:45:00 2022 ] -- [Author ID2: at Fri Mar 25 19:45:00 2022 ]thank you very much.

That was my only question.

Thank you.[Author ID2: at Fri Mar 25 19:45:00 2022 ]

Thanks [Author ID2: at Fri Mar 25 19:46:00 2022 ]is [Author ID2: at Fri Mar 25 19:46:00 2022 ]again, I'll be short and sweet,[Author ID1: at Fri Mar 25 13:08:00 2022 ][Author ID2: at Fri Mar 25 19:46:00 2022 ].[Author ID2: at Fri Mar 25 19:46:00 2022 ] Dana a couple quarters ago.[Author ID2: at Fri Mar 25 19:46:00 2022 ],[Author ID2: at Fri Mar 25 19:46:00 2022 ] I inquired about the VevaDerm[Author ID2: at Fri Mar 25 19:46:00 2022 ] [Author ID2: at Fri Mar 25 19:46:00 2022 ]very Durham [Author ID2: at Fri Mar 25 19:46:00 2022 ]you were in the [Author ID2: at Fri Mar 25 19:46:00 2022 ]potential discussions with interested partners, any progress on that product?

Yeah. Thank you for that question.

So yeah, absolutely correct. We were in discussions at [Author ID2: at Fri Mar 25 19:47:00 2022 ]with [Author ID2: at Fri Mar 25 19:47:00 2022 ]a large company and that company had some reorganization.

The project was put on hold for a while and received recently approved. So we are again [Author ID2: at Fri Mar 25 19:47:00 2022 ]get [Author ID2: at Fri Mar 25 19:47:00 2022 ]moving forward with discussions, but at that point we had to be on hold for quite a while because of some reorganization at that company.

Okay. Thank you.

And then I guess this goes a time [Author ID2: at Fri Mar 25 19:47:00 2022 ]to Tommy [Author ID2: at Fri Mar 25 19:47:00 2022 ]with the THC platform of [Author ID2: at Fri Mar 25 19:48:00 2022 ]part, that form of [Author ID2: at Fri Mar 25 19:48:00 2022 ]products that you have, is that still are you prevented from discussing with other partners, whether this [Author ID2: at Fri Mar 25 19:48:00 2022 ]y this to a , [Author ID2: at Fri Mar 25 19:48:00 2022 ]legal issue is being resolved?

It depends on the technology. Some technologies, we cannot approach the partner because they were exclusively given to Tilray.

Some other technologies are not partnered with Tilray and could be open, but at this, at this [Author ID2: at Fri Mar 25 19:48:00 2022 ]point, we're trying to get clarity on the Tilray situation, through arbitration, and then make sure that we have -- [Author ID2: at Fri Mar 25 19:49:00 2022 ]we're clear to go and able to be in the market because it's a strategic opportunity for us to be in this field. So we hope that the arbitration will be,[Author ID2: at Fri Mar 25 19:49:00 2022 ] shorter than the court proceedings.

So normally arbitration could be quite expedient. So that's what we're hoping for.

And we will make sure that this is dealt with as soon as possible. But in the meantime, we could still be discussing some opportunities with Cannabis Company, whether it's CBD or THC.

Okay, thank you for that. And, and the [Author ID2: at Fri Mar 25 19:49:00 2022 ]just do you expect a long drawn out trial with, against bio delivery down in Delaware?

I know it's scheduled for April. Do you expect that to be?

It is still scheduled for April. We're expected that the trial will go ahead as of today.

you never know before trial, there could be a settlement, but right now we're, we're [Author ID2: at Fri Mar 25 19:50:00 2022 ]expecting to trial late April.

Okay. And that's all the questions I have.

Thank you.

Okay. the line was a little distorted, but I understand we're done with the question.

So this would then conclude our Q4 and, and [Author ID2: at Fri Mar 25 19:51:00 2022 ]year-end 2021 investor update call. And I would,[Author ID2: at Fri Mar 25 19:51:00 2022 ] once [Author ID2: at Fri Mar 25 19:51:00 2022 ]again like to thank the entire team for its hard work and dedication, [Author ID2: at Fri Mar 25 19:51:00 2022 ]our[Author ID2: at Fri Mar 25 19:52:00 2022 ] [Author ID2: at Fri Mar 25 19:52:00 2022 ] [Author ID2: at Fri Mar 25 19:52:00 2022 ]board of directors for their[Author ID2: at Fri Mar 25 19:52:00 2022 ] continued support of the management team, and finally our investors for continuing to believe in and supporting us.

Thank you and goodbye.